Breast Cancer FemaleReliefNCT01738685
Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy
A study testing Behavioral Intervention. and Nutritional Education. in people with Breast Cancer Female, run by University of Pittsburgh at 1 site in United States.
Trial summary
Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Behavioral Intervention. and Nutritional Education.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50.
- Nonmetastatic bread cancer survivors reporting being bothered by 1 or more symptoms related to their treatment with AET (for > 0 months and < 6 months).
- Possess a household or cell telephone.
- Ability to provide informed consent.
Who cannot join
- Clinically significant cognitive impairment.
- Communication barrier limiting ability to participate in telephone assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy.
Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. I propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.
- Conditions
- Breast Cancer Female
- Being tested
- Behavioral Intervention., Nutritional Education.
- Keywords
- Breast Cancer., Adjuvant Endocrine therapy.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention.Behavioural
Nutritional Education.Other
| Study group | Role | What they receive |
|---|---|---|
| Control. | Other | Nutritional Education. Receives: Other: Nutritional Education. |
| Behavioral Intervention | Other | Behavioral Intervention. Receives: Behavioral: Behavioral Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction determined by the Client Satisfaction Survey
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: No funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Van Londen, Gijsberta, University of Pittsburgh
- Investigators
- G van Londen, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738685
- Sponsor's protocol ID
- PRO12050094
- Acronym
- Relief
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2012
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy.
- ClinicalTrials.gov ID
- NCT01738685
- Acronym / sponsor ID
- Relief / PRO12050094
- Conditions
- Breast Cancer Female
- Keywords
- Breast Cancer., Adjuvant Endocrine therapy.
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. I propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control. | Other | Other: Nutritional Education.Nutritional Education. |
| Behavioral Intervention | Other | Behavioral: Behavioral Intervention.Behavioral Intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50.
- Nonmetastatic bread cancer survivors reporting being bothered by 1 or more symptoms related to their treatment with AET (for > 0 months and < 6 months).
- Possess a household or cell telephone.
- Ability to provide informed consent.
Key exclusion criteria (2 listed)
- Clinically significant cognitive impairment.
- Communication barrier limiting ability to participate in telephone assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Intervention. | Behavioural | Behavioral Intervention |
| Nutritional Education. | Other | Control. |
Primary outcome
Satisfaction determined by the Client Satisfaction Survey
Time frame: Up to 6 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G van Londen, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention. and Nutritional Education. in people with Breast Cancer Female, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction determined by the Client Satisfaction Survey (time frame: Up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.